AnxietyNCT02261558
Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
A study testing Clinical Improvisation Instrumental Music Therapy and Clinical Vocal Improvisation in people with Anxiety, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Clinical Improvisation Instrumental Music Therapy and Clinical Vocal Improvisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and older
- diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer
Who cannot join
- Under 18
- past cancer(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis Scale).
Read the detailed description
The purpose of this research study is to examine clinical music therapy's impact on the resiliency of adults undergoing infusion therapy. This research study is being undertaken to learn about how creative music therapy modalities can affect the infusion therapy process. Infusion therapy often includes side effects which impact quality of life. Symptoms include pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to scheduling treatments and side effects. Typically patients receiving infusion therapy have no alternative focus for their mind and or body aside from the Infusion itself. Since the relationship between pain and anxiety is inter-related, altering one modality through a live music intervention may modify the impact of the other modality thus shifting the cycle and overall impact of pain and anxiety providing relief which leads to self soothing control measures. The current research will enroll patients newly diagnosed with either Lung, Breast, or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal improvisation or control. All enrolled participants will complete a survey which indicates their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).
- Conditions
- Anxiety
- Being tested
- Clinical Improvisation Instrumental Music Therapy, Clinical Vocal Improvisation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Improvisation Instrumental Music TherapyOther
Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes)
Clinical Vocal ImprovisationOther
- 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Clinical Improvisation Instrumental Music Therapy | Experimental | Clinical Music Therapy session, 20 minutes. Focus on instrumental improvisation Receives: Other: Clinical Improvisation Instrumental Music Therapy |
| Clinical Vocal Improvisation | Experimental | Clinical Music Therapy session, 20 minutes. Focus on vocal improvisation Receives: Other: Clinical Vocal Improvisation |
| Control Group | No intervention | Participants enrolled in control group will complete the same study design, without having a clinical music improvisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resiliency Scale
Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. . The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors. Resilience as measured through quantitative scale Wagnild, \& Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.
Measured: At 6 months
Secondary outcomes (8)
Hospital Anxiety and Depression Scale (HADS)
The HADS provides entry and final treatment endurance in coping strategies related to anxiety and depression during disease treatment trajectories.
Measured: At 6 months
Music Psychotherapy Data Tool
An informative questioner regarding the participant's musical preferences- favorite genres, artists or songs, and music history ( if applicable)- exposure to music through family members, and/or history of participation in a musical activity (such as social or private classes)
Measured: At 6 months
Visual Analogue Scale (VAS)
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
Measured: At 1 month
Visual Analogue Scale (VAS)
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
Measured: At 3 months
Visual Analogue Scale (VAS)
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
Measured: At 6 months
Body Pain Scale - Color Analysis Scale (CAS)
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
Measured: At 1 month
Body Pain Scale - Color Analysis Scale (CAS)
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
Measured: At 3 months
Body Pain Scale - Color Analysis Scale (CAS)
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJun 2011
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Loewy, MT-BC, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261558
- Sponsor's protocol ID
- GCO 16-0838
- Other IDs
- 09-090
- Status last verified
- Jan 2020
- First submitted
- 24 Jul 2014
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
PubMed 34637527Mondanaro JF, Sara GA, Thachil R, Pranjic M, Rossetti A, EunHye Sim G, Canga B, Harrison IB, Loewy JV. The Effects of Clinical Music Therapy on Resiliency in Adults Undergoing Infusion: A Randomized, Controlled Trial. J Pain Symptom Manage. 2021 Jun;61(6):1099-1108. doi: 10.1016/j.jpainsymman.2020.10.032. Epub 2020 Nov 2.
PubMed 33152443
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
- ClinicalTrials.gov ID
- NCT02261558
- Acronym / sponsor ID
- GCO 16-0838
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis Scale).
Detailed description
The purpose of this research study is to examine clinical music therapy's impact on the resiliency of adults undergoing infusion therapy. This research study is being undertaken to learn about how creative music therapy modalities can affect the infusion therapy process. Infusion therapy often includes side effects which impact quality of life. Symptoms include pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to scheduling treatments and side effects. Typically patients receiving infusion therapy have no alternative focus for their mind and or body aside from the Infusion itself. Since the relationship between pain and anxiety is inter-related, altering one modality through a live music intervention may modify the impact of the other modality thus shifting the cycle and overall impact of pain and anxiety providing relief which leads to self soothing control measures. The current research will enroll patients newly diagnosed with either Lung, Breast, or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal improvisation or control. All enrolled participants will complete a survey which indicates their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical Improvisation Instrumental Music Therapy | Experimental | Other: Clinical Improvisation Instrumental Music TherapyClinical Music Therapy session, 20 minutes. Focus on instrumental improvisation |
| Clinical Vocal Improvisation | Experimental | Other: Clinical Vocal ImprovisationClinical Music Therapy session, 20 minutes. Focus on vocal improvisation |
| Control Group | No intervention | –Participants enrolled in control group will complete the same study design, without having a clinical music improvisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 and older
- diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer
Key exclusion criteria (2 listed)
- Under 18
- past cancer(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Improvisation Instrumental Music TherapySelect an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes) | Other | Clinical Improvisation Instrumental Music Therapy |
| Clinical Vocal Improvisation* 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes) | Other | Clinical Vocal Improvisation |
Primary outcome
Resiliency Scale
Time frame: At 6 months
Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. . The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors. Resilience as measured through quantitative scale Wagnild, \& Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.
8 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 6 months
Music Psychotherapy Data Tool
Time frame: At 6 months
Visual Analogue Scale (VAS)
Time frame: At 1 month
Visual Analogue Scale (VAS)
Time frame: At 3 months
Visual Analogue Scale (VAS)
Time frame: At 6 months
Body Pain Scale - Color Analysis Scale (CAS)
Time frame: At 1 month
Body Pain Scale - Color Analysis Scale (CAS)
Time frame: At 3 months
Body Pain Scale - Color Analysis Scale (CAS)
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 34637527Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
- Derived from this study: PubMed 33152443Mondanaro JF, Sara GA, Thachil R, Pranjic M, Rossetti A, EunHye Sim G, Canga B, Harrison IB, Loewy JV. The Effects of Clinical Music Therapy on Resiliency in Adults Undergoing Infusion: A Randomized, Controlled Trial. J Pain Symptom Manage. 2021 Jun;61(6):1099-1108. doi: 10.1016/j.jpainsymman.2020.10.032. Epub 2020 Nov 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Loewy, MT-BC principal investigator
Mount Sinai Beth Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Improvisation Instrumental Music Therapy and Clinical Vocal Improvisation in people with Anxiety, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resiliency Scale (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.